Posts Tagged ‘Dermagraft’

New Dermagraft Coding to Streamline Reimbursement Process for Medicare Providers

Monday, January 17th, 2011

New Reimbursement Codes Assigned

Advanced BioHealing, Inc. (ABH), a leader in commercializing cell-based therapies and delivering on the promise of regenerative medicine, today announced the Centers for Medicare and Medicaid Services (CMS) has assigned two new procedure codes for the application of Dermagraft®, effective January 1, 2011. Dermagraft is an FDA-approved cell-based therapy for the treatment of diabetic foot ulcers and is indicated for up to eight weekly applications over a twelve-week period.

The new Healthcare Common Procedure Coding System (HCPCS) codes, which will include site preparation and debridement and 0-day global billing period, will streamline the reimbursement process for Medicare providers, enabling physicians to receive appropriate compensation for each application of Dermagraft, in accordance with its FDA-approved indication and directions for use.

The Dermagraft product code (HCPCS Q4106) will remain unchanged.

“Advanced BioHealing has been working closely with CMS officials to ensure consistent coding for Dermagraft. These efforts resulted in the creation of new codes, which will ensure that payment is made appropriately for Dermagraft each time a covered service is provided, thereby reducing administrative burden for both Medicare providers and contractors,” said Kevin Rakin, Chairman and Chief Executive Officer for ABH. “Like diabetes, diabetic foot ulcers are a growing epidemic, so streamlining access to advanced therapies like Dermagraft will help reduce the need for lower extremity amputation and additional significant costs to both the Medicare system and beneficiaries.”

More than one million physicians and health care professionals are paid under Medicare’s fee schedule, and its rules cover more than 7,000 types of services in physician offices, hospitals and other health care settings.

These new codes were established in a final ruling released by CMS on November 3, 2010. The final rule is consistent with the initial Medicare Physician Fee Schedule Proposed Rule released on June 25, 2010.

For more information, please visit the Dermagraft Reimbursement Support Center.

About Advanced BioHealing, Inc.
Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®
Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 250,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

Sources: Wound Care Insider and Advanced Biohealing

Dermagraft and Diabetic Foot Ulcers

Thursday, January 13th, 2011

Dermagraft

As Wound Care Certified Professionals, it is with certainty that we have come across and treat patients with diabetic foot ulcers. Its a growing epidemic among the population of people who suffer from diabetes. So what modalities and treatment regimens are you utilizing to deliver the care to the patients who suffer from these ulcerations? One such product that is being used in the Operating rooms, Surgi-centers and Outpatient Wound Care Centers is a product called Dermagraft.

Below is a brief video about Dermagraft, followed by some information that I found on Dermagraft’s Website.

Dermagraft® is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold.

Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines to create a three-dimensional human dermal substitute containing metabolically active, living cells. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles.

Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2” x 3” for a single-use application.

Dermagraft Overview

  • Description – Human fibroblast-derived dermal substitute
  • Composition – Composed of human fibroblasts, extracellular matrix, and bioabsorbable scaffold; does not contain macrophages, lymphocytes, blood vessels, or hair follicles
  • Cultured In Vitro
  • Mode of Action – Re-epithelialization — assists in the restoration of the dermal bed, allowing wounds to heal (when implanted into adequately prepared diabetic foot ulcers)
  • Primary Indication – For use in the treatment of full-thickness diabetic foot ulcers
  • Product Number – 11045

Dermagraft Indication

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot.

Contraindications:

  • Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts
  • Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution

Adverse events included local wound infection, osteomyelitis, and/or cellulitis.1

Dermagraft Safely Gets Patients Back in Action

Proprietary Cryopreservation Process Ensures Confidence

Dermagraft is cryopreserved to allow long-term maintenance of tissue integrity and cellular viability. Cryopreservation of Dermagraft offers a number of additional product benefits:

  • Allows for safety testing prior to shipping and application
  • Provides longer shelf life-long-term storage (up to 6 months) when stored at -75°C ± 10°C

There have been no reported immunological responses or rejections from patients that received Dermagraft.

Manufacturing Safety

Each lot of Dermagraft is tested and results are known before it is released.

Final product microbiological testing:

  • Final product sterility
  • Endotoxin (cryopreservation solution)
  • Endotoxin (tissue)
  • Mycoplasma by DNA fluorochrome stain
  • Direct cultivation of mycoplasma
(28 day test by approved 3rd party laboratory)

Adverse Events

Dermagraft was safe and well-tolerated. The most common adverse effects occurring in the Dermagraft (n=163) and control (n=151) groups included all randomized patients, respectively, were infection at study wound (10.4% vs 19.9%), infection not at study wound all randomized patients (10.4% vs 9.3%), accidental injury (10.4% vs 11.9%), and skin dysfunction/blister (9.8% vs 13.2%). The overall incidence of adverse events was approximately the same for both the Dermagraft and control groups. No adverse laboratory findings were associated with the use of Dermagraft and no adverse device effects were reported in the study. The number of patients who developed study ulcer-related adverse events (ie, local wound infection, osteomyelitis, cellulitis) was significantly lower in the Dermagraft-treated group (19%) as compared with the control group (32.5%, P=0.007; Table 3).

Event Dermagraft (n=163) Control (n=151)
Infection 17 (10.4%)* 27 (17.9%)
Osteomyelitis 14 (8.6%) 13 (8.6%)
Cellulitis 12 (7.4%) 14 (9.3%)
Overall 31 (19.0%)† 49 (32.5%)

*P=0.073 vs control; †P=0.007 vs control.

For full safety information, please reference the Dermagraft Directions for Use.

Advanced BioHealing, Inc, (ABH) is a leader in regenerative medicine focused on the development and marketing of cell-based and tissue-engineered products. For more information about ABH and Dermagraft, visit www.ABH.com, or click here for other inquiries.

References
  1. Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):1701-1705.
  2. http://www.Dermagraft.com

I was able to find another video from Advanced BioHealing on the Manufacturing Process. It may be useful to understand the overview:

For more information about Dermagraft please visit their website at http://www.Dermagraft.com

For more information about becoming Wound Care Certified, please visit http://www.wcei.net.